YY/T 1164-2021 Active Industry standards-Medicine

YY/T 1164-2021 Human chorionic gonadotropin (HCG) detection kit(colloidal gold immunochromatographic assay)

YY/T 1164-2021 Human chorionic gonadotropin (HCG) detection kit(colloidal gold immunochromatographic assay)

Publish Date: 2021-12-06 Implement Date: 2022-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1164-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-12-06

Implement Date: 2022-12-01

Pages: 10 pages

Scope

This document specifies the terms and definitions, technical requirements, test methods, labels and user manuals, packaging, transportation, and storage for human chorionic gonadotropin (HCG) detection kits (colloidal gold immunoassay) (hereinafter referred to as HCG test strips).
This document is applicable to kits that use the colloidal gold immunoassay principle to perform qualitative and semi-quantitative detection of HCG levels in human urine samples.

Development Information

Word Count: 22 Thousand words Pages: 10 pages

Replace the following standards

YY/T 1164-2009

Referenced Standards

GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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